Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months

NCT ID: NCT04491773

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-05-30

Brief Summary

This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography angiography.

Detailed Description

Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection.

This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography features after the somministration of Tadalafil 20 mg orally for more than 6 months.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing Tadalafil

Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months

Tadalafil 20 MG

Intervention Type: DRUG

To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.

Control Group

Healthy controls without previous surgery of radical prostatectomy.

No interventions assigned to this group

Interventions

Tadalafil 20 MG

To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.

Intervention Type: DRUG

Other Intervention Names

Cialis

Eligibility Criteria

Inclusion Criteria

• age older than 45 years
• diagnosis of erectile dysfunction due to surgery of radical prostatectomy
• treatment-naïve with Tadalafil for erectile dysfunction for more than 6 months
• absence of diabetes, heart diseases, hypertension
• absence of drug intake
• absence of vitreoretinal, vascular retinal diseases
• absence of previous ocular surgery and congenital eye diseases.
• absence of errors of refraction
• absence of lens opacities
• absence of low-quality OCT and OCTA images

Exclusion Criteria

• age younger than 45 years
• diagnosis of erectile dysfunction due to other causes
• previous treatments before Tadalafil for erectile dysfunction
• presence of diabetes, heart diseases, hypertension
• drug intake
• vitreoretinal and vascular retinal diseases
• previous ocular surgery and congenital eye diseases
• errors of refraction
• lens opacities
• low-quality OCT and OCTA images

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gilda Cennamo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilda Cennamo

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

University of Naples "Federico II"

Naples, , Italy

Countries

Italy

Other Identifiers

1516/19

Identifier Type: -

Identifier Source: org_study_id